the Effect of Formulation on Anxiety in Autist Childre A Randomized Controlled Trial Assesses Spirulina Syrup Plus Risperidone in Children With Non-idiopathic Autism. Anxiety is Measured Using the SCAS (Parent Version) Via Daily Online Surveys for One Week and Throughout a 3-month Follow-up Period.

NCT07060872 | Not Yet Recruiting

• 1 other identifier: IR.SSU.REC
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of a Spirulina syrup formulation on reducing anxiety in children with non-idiopathic autism. Participants are referred to a private clinic and assessed by a pediatric neurology subspecialist to confirm the diagnosis. Informed consent is obtained from the parents. Patients are randomly assigned to two groups. The intervention group receives standard treatment (Risperidone tablets) plus Spirulina syrup, while the control group receives Risperidone plus a placebo. Anxiety is measured using the parent version of the Spence Children's Anxiety Scale (SCAS), which includes 38 items rated on a 4-point Likert scale. The questionnaire is administered online via the Porsline platform, and links are sent nightly via social media starting before treatment and continuing daily for one week after treatment initiation, then regularly over a 3-month follow-up period. Data will be analyzed using SPSS version 16. The SCAS consists of six subscales: separation anxiety, social anxiety, phobia, generalized anxiety, panic, and obsessive-compulsive symptoms.

Conditions

Age 3 to 7 Years; Mild Autism Spectrum; no Other Illness or Disorder

Keywords

Autism; Anxiety; Spirulina; Pharmaceutical supplement

Outcome Measures

Primary Outcomes (1)

• Change in anxiety symptoms based on the Spence Children's Anxiety Scale (Parent Version) total score

  Anxiety symptoms will be assessed using the Spence Children's Anxiety Scale (SCAS) - Parent Version, a 38-item validated tool. Total score changes will be used to evaluate treatment efficacy.

  From baseline to 3 months after treatment initiation

Secondary Outcomes (1)

• Change in subscale scores of SCAS (e.g., separation anxiety, social anxiety, generalized anxiety, etc.)

  From baseline to 3 months after treatment initiation

Study Arms (2)

Spirulina Syrup

EXPERIMENTAL

* Spirulina Syrup * Risperidone

Dietary Supplement: Spirulina Syrup; Drug: Risperidone

Placebo Syrup

PLACEBO COMPARATOR

* Placebo Syrup * Risperidone

Dietary Supplement: Placebo Syrup; Drug: Risperidone

Interventions

Spirulina Syrup DIETARY_SUPPLEMENT

A natural dietary supplement derived from Spirulina algae, administered orally as a syrup formulation. Used as an adjunct therapy to assess its potential effect on reducing anxiety symptoms in children with non-idiopathic autism. Dosage and duration are standardized according to study protocol.

Spirulina Syrup

Placebo Syrup DIETARY_SUPPLEMENT

Placebo Syrup

Placebo Syrup

Risperidone DRUG

Risperidone

Placebo Syrup; Spirulina Syrup

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with non-idiopathic autism, confirmed by a pediatric neurology subspecialist
• Age range: \[3 to 7 years\]
• Parental informed consent obtained
• Ability to complete online anxiety questionnaires with parental assistance

You may not qualify if:

• Presence of other major neurological or psychiatric disorders
• Known allergy or intolerance to Spirulina or Risperidone
• Participation in other clinical trials within the past 3 months
• Severe medical conditions that contraindicate the use of study medications

Sponsors & Collaborators

• Shahid Sadoughi University of Medical Sciences and Health Services: lead

Study Sites (1)

Sanaz Alamdar

Yazd, 8917634787, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Autistic Disorder; Anxiety Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Sanaz Alamdar, M.s

CONTACT

+989132738977; Sani.deol1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Model Details: A group of 41 people took the formulation and a group of 41 people took a placebo

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 7, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

IR (1)